Real Time Release Testing (Parametric Release) - EMA publishes new Guideline Draft open for Consultation

The EMA published in February the draft of a new Guideline for Real Time Release Testing (formerly Guideline on Parametric Release). The draft is open for comments until end of August 2010.

The guideline proposes an outline of the requirements for applications that propose RTR testing for active substances, intermediates and finished products. The guideline highlights the different requirements that have to be fulfilled in the application and the role of related inspections (pre authorization and routine GMP inspections), RTR testing for active substances, intermediates and finished products.

The recent guidelines, adopted in the course of the international harmonisation process, like ICH Q7, Q8 and Q9 facilitate the application of a similar release strategy. Up to now, the concept of a parametric release applies only to sterility testing. With the ICH guidelines, the possibility of  a Real Time Release Testing strategy to tests other then sterility was given. This guideline addresses the requirements for application of RTR testing to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR testing. The guideline replaces the previous guideline on parametric release and does not introduce new requirements, so the parametric release part on the previous guideline is retained unchanged.

This guideline elaborates on the application of RTR testing to a number of areas of pharmaceutical development and manufacture, in addition to sterilisation. It will thereby replace the “Note for Guidance on Parametric Release".

The complete draft can be found here.

The ECA "3rd European Microbiology Conference" in Barcelona, Spain, on 4-5 May 2010 covers, amongst others, the topic of Parametric Release with lectures from regulatory authorities and industry.

Axel Schroeder
On behalf of the European Compliance Academy (ECA)

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